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March 2003
IN THIS ISSUE

New ESCRS trial in bid to cut endophthalmitis rate to 0.01%


Lasik corrects refractive errors after PK in selected patients

Africa-Luz mobilises to provide eye care in regions riven by poverty

Multifocal IOL
choice hinges on patterns of daily routine

Anti-histamine drug mitigates risk of developing DLK after Lasik, says study

Untreated eyelid inflammatory disorders pose risk for postoperative complications

Thermotopography shows ‘enormous promise’
for diagnosis and treatment of eye diseases

Lasik offers ‘very effective treatment’ for
refractive errors after PK, says US specialist

Good results with PRK and Lasek rival Lasik for top spot in refractive excimer laser surgery

Orbital lymphomas respond well to local, systemic therapies, says study

Laser technologies still beam but economy and consumer demand will determine future of refractive surgery

Legally blind cardiologist finds new beat in low vision rehabilitation

‘Pivotal’ anti-TGF antibody therapy reduces
filtering bleb wound formation, says report

Neuroprotective agents stem optic nerve damage
by ‘offering a solution’ to open-angle glaucoma

Echothiophate iodide shortage leaves US specialists struggling to find alternative for acute cases

Postoperative complications of PK will have serious consequences unless tackled 'aggressively’

Private refractive clinics claim young specialists as public waiting lists grow in Canadian eye surgery

German doctors’ helpers oil the cogs of the private ophthalmic practice

Study of 900 ICLs reveals good safety and long-term refractive results, says Spanish specialist

New toric IOL corrects high corneal astigmatism after cataract surgery, Austrian study reveals

IVF children run increased risk of developing
retinoblastoma, claim Dutch researchers

Suture-free DLEK preserves corneal surface topography and ensures faster wound healing

The day I said goodbye to cataracts and hello to the world without glasses

Retina specialists and trauma ophthalmologists
prepare to trade notes at joint Hungarian conference

Night blindness casts bogeyman into the shadows

Erbium laser phaco requires longer time but less energy for moderately hard cataracts

FEATURES
From The Editor
Reflections on Refractive Surgery
In Your Good Books
Bio-ophthalmology
In The Driving Seat
Prime Site
The Collector's Eye
Regulatory Matters



When a proactive approach can head off malpractice lawsuits

JUDGING from the sentiment at the 7th ESCRS Winter Refractive Meeting, many ophthalmologists appear resigned to the prospect of appearing in a courtroom to defend their treatment.

Increasing numbers of ophthalmologists are coming to realise, however, that they possess the power to reduce the risk of being sued and of ever appearing in court.
Exercising that power begins with understanding why patients sue.

A recent landmark study has found that a surgeon’s attitude may play a part in indicating whether a patient sues for malpractice (Surgery 2002;132:5-9). The study represents the first of its kind to indicate that the manner in which something is said to a patient may be as important as what is said in determining the risk of a malpractice lawsuit.
In the study, US researchers examined consultations between surgeons and their patients. Half of the surgeons had been sued for malpractice at least once. The other half had never been sued.

After deleting identifying information from the consultations, the researchers picked out four 10-second sound bites from each consultation between the surgeon and two different patients. The researchers played the sound bites to a ‘jury’ of six lay men and six lay women. The researchers then asked the jury to rate the surgeon’s tone of voice according to whether the surgeon seemed:

• Warm
• Anxious or Concerned
• Interested
• Hostile
• Sympathetic
• Professional
• Competent
• Dominant
• Satisfied
• Genuine

The study found that those surgeons who received high marks for a dominant tone and low marks for a concerned or anxious tone were 2.74 times more likely to have already been sued. Those surgeons who scored high marks for an anxious or concerned tone and low marks for a dominant tone were only half as likely to have ever been sued.

Heading off lawsuits before they happen may seem an onerous task, but another recent study may point the way. That study indicates that dealing with patient complaints early may help reduce the risk of those patients taking their complaints to court. (Journal of the American Medical Association 2002;287:2951-2957)
In the study, researchers looked at 18,851 unsolicited patient complaints at a major academic hospital in the US.

In designing the study, the researchers said they hoped to alert physicians to a number of non-clinical factors that may influence patients to complain and sue.
“Risk appears related to patients’ dissatisfaction with their physicians’ ability to establish rapport, provide access, administer care and treatment consistent with expectations and communicate effectively,” the researchers explained.
During the six-year duration of the study, 406 of the hospital’s 645 physicians received at least one complaint. In all, patients identified at least one physician’s name in 5,108 complaints; of those 5,108 complaints, 56% identified a surgeon, including a number of ophthalmologists.

When the researchers looked more closely at who was sued they found that 9% of the hospital physicians accounted for more than half of all patient complaints. What was even more startling was that 5% of the hospital’s physicians accounted for almost one-third of all patient complaints.
The researchers also found that physicians with more complaints against them were more likely to be sued by such unhappy patients.

“The identification of an association between complaint data and risk management activity offers an excellent opportunity for addressing sources of patient dissatisfaction that can lead inappropriately toward the courtroom,” the researchers concluded.
Such findings aren’t exclusively American, either. For years, European physicians have known that non-clinical factors are sometimes as important as the clinical ones in determining whether a patient sues for negligence.
About a decade ago, British psychiatrists undertook a landmark study to understand why patients sue. The results ring true as loudly as they did when they appeared in the The Lancet in June of 1994 (343:1609-1613)

The psychiatrists reviewed responses to questionnaires from 227 patients and relatives who had hired lawyers to sue for medical malpractice. Of the lawsuits, 42 arose over injury during surgery; 70 arose over failures to diagnose; 42 arose because of over incorrect treatment; 33 arose over injury at birth and 10 arose over adverse drug reactions.

When patients were asked to describe their immediate reactions to the incident:

• 90% said they were angry
• 80% said they were bitter
• 55% felt betrayed
• 40% felt humiliated

When patients and their relatives were asked about whether they had ever received an explanation for what happened to them or their family member, more than a third of them said they never received any explanation.
Of the patients and relatives who did receive an explanation, a majority were dissatisfied with the explanation. The study found that:

• 11.3% thought they received enough information
• 24.3% thought the information they received was clear
• 20.2% thought the information was accurate
• 39.3 thought the information as given sympathetically

The study also found that a physician accepted responsibility for the incident in only 13% of cases and that the patient or relative received an apology in only 15% of cases.
Patients were then asked to review a list of reasons why they sued and to indicate whether they agreed with the reason. The most common reason, with which 91.4 % of respondents agreed, was that they sued “so that it would not happen to anyone else”.

Other common reasons included:

• I wanted an explanation: 90.7%
• I wanted the doctors to realise what they had done: 90.4%
• To get an admission of negligence: 86.7%
• So that the doctor would know how I felt: 68.4%
• My feelings were ignored: 66.8%
• I wanted financial compensation: 65.6%
• Because I was angry: 65.4%
• So that the doctor did not get away with it: 54.7%
• So that the doctor would be disciplined: 47.6%
• Because it was the only way I could cope with my feelings: 45.8%
• Because of the attitude of the staff afterwards: 42.5%
• To get back at the doctor involved: 23.2%

From the findings, the British psychiatrists concluded that patients take their physicians to court for more than just money. Four main themes emerged from the analysis of reasons for litigation:

• Standards of care: Both patients and relatives wanted to prevent similar incidents in the future
• Explanation: To know how it happened and why;
• Compensation: For financial losses, pain and suffering or to provide care in the future for an injured person
• Accountability: Consideration that an individual or organisation should be held responsible.

Most European legal systems, however, are ill-equipped to tackle all four areas. As a result, physicians — including ophthalmologists must change more than their country’s legal systems to deter patients from suing. They must change the way they communicate with patients and the way in which they react to errors and complaints.
With such changes, ophthalmologists may be able to take more control of their malpractice risk. In such a way, ophthalmologists can satisfy many disappointed patients — even those with poor outcomes — and help reduce the risk that they will end up in court defending a malpractice lawsuit.

Honesty is best to reduce malpractice lawsuits

Strangely enough, admitting mistakes right from the start may help reduce the risk — and cost — of being sued for malpractice, according to the US Department of Veteran Affairs.

The Department, which runs hospitals for the country’s military veterans, has recently introduced a policy of admitting medical errors as soon as they happen. Under the policy, the hospital informs patients and their families of any negligence or accidents as soon as they learn of them and to “assure them that medical measures have been implemented and that additional steps are being taken to minimise disability, death, inconvenience or financial loss to the patient or family”.

As part of the disclosure process, hospital officials, including the hospital’s chief of staff, meet with the patient and family members as soon as possible after the incident.

At that meeting, the hospital officials provide an explanation of the accident or error and, when possible, identify those hospital staff members responsible. As part of the meeting, the hospital officials apologise for any mistake and promise to undertake whatever means are necessary to prevent the error recurring.

Also as part of the process, the hospital will help the patient and family members complete whatever compensation forms may be required. The hospital will even recommend that patients and their family members talk to their own lawyers about any compensation offers and meet with such lawyers to work out a compensation package based on a reasonable calculation of the patient’s injury and loss.

During the seven years that one veterans’ hospital monitored the full disclosure programmes, it recorded 88 malpractice claims (Annals of Internal Medicine 1999;131:963-967). Those claims included five settlements in which the hospital made payments for serious injury or death in circumstances where the patient or family would never have known of the underlying negligence.

The hospital paid out an average of $15,622 to settle the claims. Only eight claims reached court. Of those, the hospital won before trial. The one case that made it to trial was won by the hospital.

In addition to saving money on payouts to patients, the hospital estimated that it saved $250,000 in legal costs for every case that did not reach court.
“An honest and forthright risk management policy that puts the patient’s interests first may be relatively inexpensive because it allows avoidance of lawsuit preparation, litigation, court judgments and settlements at trail.

“Although goodwill and the maintenance of the care-giver role are less tangible benefits, they are also important advantages of such a policy,” the researchers concluded.


If you have any suggestions for future Regulatory Matters columns, please contact Paul McGinn at +353 1 628 9747 or email paulrmcginn@eircom.net.

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